Bipolar Disorder Depression Clinical Trial
Official title:
Minocycline and Aspirin in the Treatment of Bipolar Depression
The purpose of this study is to determine whether minocycline and aspirin are effective in the treatment of depression in individuals with bipolar disorder.
Abstract:
New medication classes are needed to improve treatment effectiveness in the depressed phase
of bipolar disorder (BD). Extant evidence suggests that BD is not only characterized by
reduced monoaminergic signaling, but also by neural changes such as dendritic remodeling,
demyelination, and glial and neuronal cell loss. These changes have been hypothesized to
result from chronic inflammation, based partly on convergent evidence that proinflammatory
cytokines are elevated in depressed patients with BD. The principal aims of the proposed
research is to evaluate the antidepressant efficacy in bipolar depression of minocycline, a
drug with neuroprotective and immune-modulating properties, and of aspirin, at doses expected
to selectively inhibit cyclooxygenase 1 (COX-1), within the context of a randomized,
double-blind, placebo-controlled, parallel-group clinical trial following a 2 x 2 design.
Specific Aims Specific Aim 1: To evaluate the efficacy of augmentation therapy with
minocycline and/or aspirin for bipolar depression.
The investigators will test the hypothesis that compared with placebo, participants receiving
minocycline and/ or aspirin will show a greater treatment response rate (defined as a >50%
increase on the MADRS for the final two consecutive visits).
Specific Aim 2: To investigate the relationship between the response to minocycline, aspirin
and markers of inflammation (serum concentrations of IL-6 and CRP).
The investigators will test the hypotheses that: a) minocycline treatment will reduce
inflammation to a greater extent than placebo; b) during minocycline treatment the change in
inflammatory cytokine expression will correlate with the change in depression ratings; c) the
baseline elevation of inflammatory markers will predict greater antidepressant response to
minocycline.
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